To Share Or Not To Share (2Share)
11 maart 2020 bijgewerkt door: Nathalie Oexle, University of Ulm
To Share or Not To Share (2Share) - Group Intervention to Support Disclosure Decisions After Suicide Attempt
The purpose of the study is to evaluate the group-based intervention "To Share Or Not To Share" in a German clinical setting.
Feasibility and efficacy of the program will be tested in a pilot randomized-controlled trial.
Studie Overzicht
Toestand
Beëindigd
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
People who have survived a suicide attempt often face public and self-stigma, and secrecy is a common strategy to minimize the risk of being labeled. Both secrecy and disclosure have pros and cons. The decision whether, when, and to whom to disclose a previous suicide attempt is complex. Interventions can provide guidance for systematic consideration and a well informed decision. Potentially, it may not be disclosure itself, but the empowered decision for or against disclosure of a previous suicide attempt that reduces distress and leads to beneficial outcomes.
The manualized peer-led group intervention "Honest, Open, Proud" (HOP) supports people with mental illness in their decision whether to disclose mental illness. Research showed positive effects of the intervention on stigma stress, disclosure-related distress and quality of life. Based on HOP, "To Share Or Not To Share" (2Share) was developed to systematically guide suicide attempt survivors through their decision whether and how to disclose a previous suicide attempt.
2Share led to significant reductions in self-stigma and depressive symptoms, as well as increased self-esteem in a recent pilot randomized-controlled trial (RCT) in the US. The aim of the current study is to evaluate 2Share in a German clinical setting. Feasibility and efficacy of 2 Share will be tested in a pilot RCT.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
4
Fase
- Fase 2
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Ulm, Duitsland, 89073
- University of Ulm and BKH Günzburg
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- Current inpatient, outpatient or day clinical treatment at the Bezirkskrankenhaus Günzburg, Germany
- Age ≥ 18 years
- At least one previous suicide attempt
- Positive screening for disclosure distress (1 item: "In general, how distressed or worried are you in terms of secrecy or disclosure of your suicide attempt?", self-report, persons with a score ≥ 4 on a scale from 1-7 are included)
- Written informed consent
- Sufficient German language skills
Exclusion Criteria:
- Current suicidality (1 item: "Have you had thoughts that you would be better off dead for at least several days during the last week?", self-report, persons responding with yes will be excluded and will be offered support)
- Suicide attempt within the last four weeks
- Dementia or organic disease (ICD-10: F0)
- Primary substance dependence (ICD-10: F1x.2)
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Intervention (2Share) + treatment as usual
Study participants randomized to the experimental group receive the intervention (2Share) while maintaining their current treatment (treatment as usual). 2Share is a peer-led group intervention containing three two-hour sessions within two weeks plus an additional booster session four weeks later. Fidelity to manual is rated in each session by study staff. |
The peer-led group program contains of three lessons plus one booster session:
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Geen tussenkomst: Treatment as usual
Participants randomized to the control group do not receive the group program but maintain their current treatment (treatment as usual).
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Self-stigma related to suicide attempt
Tijdsspanne: 2 weeks
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Self-Stigma of Suicide Attempt Survivor Scale (SSSAS), 14-item apply subscale (Sheehan et al, 2018); each item is rated from 1-9, we will calculate a sum score accross all items (range 9-126) with higher scores indicating more self-stigma.
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2 weeks
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Self-stigma related to suicide attempt
Tijdsspanne: baseline, 6 weeks, 12 weeks
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Self-Stigma of Suicide Attempt Survivor Scale (SSSAS), 14-item apply subscale (Sheehan et al, 2018); each item is rated from 1-9, we will calculate a sum score accross all items (range 9-126) with higher scores indicating more self-stigma.
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baseline, 6 weeks, 12 weeks
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Self-Stigma (alienation) related to suicide attempt
Tijdsspanne: baseline, 6 weeks, 12 weeks
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Internalized Stigma of Mental Illness scale (ISMI), 6-item alienation subscale (Ritsher et al. 2003) adapted for suicide attempt, 6 items rated from 1-4, we will calculate a mean score accross all items (range: 1-6) with higher scores indicating more self-stigma.
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baseline, 6 weeks, 12 weeks
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Stigma stress related to suicide attempt
Tijdsspanne: baseline, 2 weeks, 6 weeks, 12 weeks
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Stigma Stress Scale (Rüsch et al., 2009a,b) adapted for suicide attempt, 8-items rated from 1-7 with 4 items measuring the primary appraisal of stigma as harmful and 4 items measuring the secondary appraisal of perceived resources to cope with stigma-related harm, for each of the two subscales we will calculate a mean score (range 1-7) and a total stigma stress score will be caclulated by subtracting perceived resources from perceived harm with higher difference scores (range -6 to +6) indicating more stigma-stress.
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baseline, 2 weeks, 6 weeks, 12 weeks
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Secrecy about suicide attempt
Tijdsspanne: baseline, 2 weeks, 6 weeks, 12 weeks
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Secrecy Scale (Link et al., 1991) adapted for suicide attempt, 5 items rated from 1-6, we will calculate a mean score accross all items (range 1-6) with higher scores indicating more secrecy.
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baseline, 2 weeks, 6 weeks, 12 weeks
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General disclosure distress
Tijdsspanne: baseline, 2 weeks, 6 weeks, 12 weeks
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Distress Disclosure Index (Kahn et al., 2001), 12 items rated from 1-5, we will calculate a sum score accross all items (range 12-60) with higher scores indicating more disclosure distress.
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baseline, 2 weeks, 6 weeks, 12 weeks
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Help-seeking for suicidality
Tijdsspanne: baseline, 2 weeks, 6 weeks, 12 weeks
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General Help-Seeking Questionnaire - suicidal ideation subscale (GHSQ-SI) (Wilson et al., 2005), 10 items rated from 1-7, we will calculate mean scores (range 1-7) for items related to social contacts (items 1-4) and care providers (items 5,7,10).
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baseline, 2 weeks, 6 weeks, 12 weeks
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Depressive symptoms
Tijdsspanne: baseline, 2 weeks, 6 weeks, 12 weeks
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Center for Epidemiological Studies-Depression Scale - short form (CES-D) (Hautzinger et al., 1993), 15 items rated from 0-3, we will calculate a sum score accross all items (range 0-45) with higher scores indicating more depressive symptoms.
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baseline, 2 weeks, 6 weeks, 12 weeks
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Suicidal ideation
Tijdsspanne: baseline, 2 weeks, 6 weeks, 12 weeks
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Suicidal Ideation Attributes Scale (SIDAS) (Spijker et al., 2014), 5 items rated from 0-10, we will calculate a total sum score accross all items (range 0-50) with higher scores indicating more suicidality.
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baseline, 2 weeks, 6 weeks, 12 weeks
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Recovery
Tijdsspanne: baseline, 2 weeks, 6 weeks, 12 weeks
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Recovery Assessment Scale - short version (RAS-G) (Corrigan et al., 2004), 24 items rated from 1-5, we will calculate a mean score accross all items (range 1-5) with higher scores indicating more recovery.
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baseline, 2 weeks, 6 weeks, 12 weeks
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Self-esteem
Tijdsspanne: baseline, 2 weeks, 6 weeks, 12 weeks
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Rosenberg's Self-Esteem Scale (RSE) (Collani et al., 2003), 10 items rated from 0-3, we will caculate a sum score accross all items (range 0-30) with higher scores indicating more self-esteem.
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baseline, 2 weeks, 6 weeks, 12 weeks
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Quality of life
Tijdsspanne: baseline, 2 weeks, 6 weeks, 12 weeks
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EUROHIS Quality of Life Index (EUROHIS-QOL) (Brähler et al., 2007), 8 items rated from 1-5, we will calculate a sum score accross all items (range 8-40) with higher scores indicating more quality of life.
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baseline, 2 weeks, 6 weeks, 12 weeks
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- Rusch N, Corrigan PW, Wassel A, Michaels P, Olschewski M, Wilkniss S, Batia K. A stress-coping model of mental illness stigma: I. Predictors of cognitive stress appraisal. Schizophr Res. 2009 May;110(1-3):59-64. doi: 10.1016/j.schres.2009.01.006. Epub 2009 Mar 6.
- Ritsher JB, Otilingam PG, Grajales M. Internalized stigma of mental illness: psychometric properties of a new measure. Psychiatry Res. 2003 Nov 1;121(1):31-49. doi: 10.1016/j.psychres.2003.08.008.
- Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
- van Spijker BA, Batterham PJ, Calear AL, Farrer L, Christensen H, Reynolds J, Kerkhof AJ. The suicidal ideation attributes scale (SIDAS): Community-based validation study of a new scale for the measurement of suicidal ideation. Suicide Life Threat Behav. 2014 Aug;44(4):408-19. doi: 10.1111/sltb.12084. Epub 2014 Feb 24.
- Link BG, Mirotznik J, Cullen FT. The effectiveness of stigma coping orientations: can negative consequences of mental illness labeling be avoided? J Health Soc Behav. 1991 Sep;32(3):302-20.
- Rusch N, Corrigan PW, Powell K, Rajah A, Olschewski M, Wilkniss S, Batia K. A stress-coping model of mental illness stigma: II. Emotional stress responses, coping behavior and outcome. Schizophr Res. 2009 May;110(1-3):65-71. doi: 10.1016/j.schres.2009.01.005. Epub 2009 Feb 23.
- Sheehan L, Oexle N, Dubke R, Wan HT, Corrigan PW. The Self-Stigma of Suicide Attempt Survivors. Arch Suicide Res. 2020 Jan-Mar;24(1):34-47. doi: 10.1080/13811118.2018.1510797. Epub 2018 Dec 1.
- Kahn JH, Hessling RM. Measuring the tendency to conceal versus disclose psychological distress. J Soc Clin Psychol. 2001;20(1):41-65. doi:10.1521/jscp.20.1.41.22254
- Wilson CJ, Deane FP, Ciarrochi JV, Rickwood D. Measuring help seeking intentions: properties of the General Help Seeking Questionnaire. Canadian Journal of Counselling. 2005;39(1):15-28. doi:10.1080/09638237.2017.1370642.
- Hautzinger M, Bailer M. Allgemeine Depressions-Skala [The German version of the Center for Epidemiological Studies-Depression scale]. Weinheim: Beltz; 1993.
- Corrigan PW, Salzer M, Ralph RO, Sangster Y, Keck L. Examining the factor structure of the recovery assessment scale. Schizophr Bull. 2004;30(4):1035-41. doi: 10.1093/oxfordjournals.schbul.a007118.
- Collani G v., Herzberg PY. Eine revidierte Fassung der deutschsprachigen Skala zum Selbstwertgefühl von Rosenberg [A revision of the German Rosenbergs self-esteem scale]. Zeitschrift für Differentielle und Diagnostische Psychologie. 2003;24(1):3-7. doi:10.1024//0170-1789.24.1.3
- Brähler E, Mühlan H, Albani C, Schmidt S. Teststatistische Prüfung und Normierung der deutschen Versionen des EUROHIS-QOL Lebensqualität-Index und des WHO-5 Wohlbefindens-Index [Psychometrics and standardization of the German version of EUROHIS-QOL quality of life index and WHO-5 wellbeing index]. Diagnostica. 2007;53(2):83-96. doi:10.1026/0012-1924.53.2.83
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
7 mei 2019
Primaire voltooiing (Werkelijk)
1 januari 2020
Studie voltooiing (Werkelijk)
1 maart 2020
Studieregistratiedata
Eerst ingediend
7 mei 2019
Eerst ingediend dat voldeed aan de QC-criteria
7 mei 2019
Eerst geplaatst (Werkelijk)
9 mei 2019
Updates van studierecords
Laatste update geplaatst (Werkelijk)
13 maart 2020
Laatste update ingediend die voldeed aan QC-criteria
11 maart 2020
Laatst geverifieerd
1 maart 2020
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 345/18
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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